Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients
NCT ID: NCT02625649
Last Updated: 2017-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
148 participants
OBSERVATIONAL
2016-01-31
2017-06-30
Brief Summary
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Detailed Description
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The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire.
More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part of the patients.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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RYGB
RYGB-operated type 2 diabetic patients
No interventions assigned to this group
non-RYGB
non-RYGB-operated type 2 diabetic controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes mellitus
* speaks and understands Danish
* presents written concent
* cases must be Roux-en-Y operated between 2006-2011.
Exclusion Criteria
* chronic inflammatory bowel disease
* ischemic heart disease
* liver disease
* cholecystectomy.
Controls can not be bariatric operated.
18 Years
60 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lene R Madsen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Madsen LR, Bek T, Richelsen B. Diabetic retinopathy in people with Type 2 diabetes and obesity treated by Roux-en-Y gastric bypass compared with non-operated controls: with focus on the role of diabetes remission in a cross-sectional and a 6-year follow-up study. Diabet Med. 2019 Apr;36(4):457-464. doi: 10.1111/dme.13876. Epub 2018 Dec 26.
Other Identifiers
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11092015
Identifier Type: -
Identifier Source: org_study_id
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